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Last Updated: March 31, 2020

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Deferasirox - Generic Drug Details

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What are the generic sources for deferasirox and what is the scope of freedom to operate?

Deferasirox is the generic ingredient in four branded drugs marketed by Novartis, Actavis Elizabeth, Alembic Pharms Ltd, Alkem Labs Ltd, Bionpharma Inc, Ichnos, MSN, Sun Pharm, Amneal Pharms Co, Piramal Hlthcare Uk, Teva Pharms Usa, Zydus Pharms, and Novartis Pharms Corp, and is included in eighteen NDAs. There are two patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Deferasirox has one hundred and six patent family members in fifty-one countries.

There are twenty drug master file entries for deferasirox. Sixteen suppliers are listed for this compound. There are nine tentative approvals for this compound.

Drug Prices for deferasirox

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Recent Clinical Trials for deferasirox

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Fondazione Italiana Sindromi Mielodisplastiche OnlusPhase 2
DisperSol Technologies, LLCPhase 2
National Cancer Institute (NCI)Phase 2

See all deferasirox clinical trials

Recent Litigation for deferasirox

Identify potential future generic entrants

District Court Litigation
Case NameDate
ALEMBIC PHARMACEUTICALS, LTD v. NOVARTIS PHARMACEUTICALS CORP.2019-11-27
Novartis Pharmaceuticals Corporation v. Teva Pharmaceuticals USA, Inc.2016-07-29
Novartis Pharmaceuticals Corporation v. Mylan Inc.2014-06-26

See all deferasirox litigation

Generic filers with tentative approvals for DEFERASIROX
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial180MGTABLET; ORAL
  Start Trial  Start Trial360MGTABLET;ORAL
  Start Trial  Start Trial90MGTABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Synonyms for deferasirox
1044764-54-6
201530-41-8
4-((3E,5E)-3,5-bis(6-oxocyclohexa-2,4-dien-1-ylidene)-1,2,4-triazolidin-1-yl)benzoic acid
4-((3Z,5E)-3,5-bis(6-oxocyclohexa-2,4-dien-1-ylidene)-1,2,4-triazolidin-1-yl)benzoic acid
4-(3,5-Bis(2-hydroxyphenyl)-1H-1,2,4-triazol-1-yl)benzoic acid
4-[(3Z,5E)-3,5-Bis(6-Oxo-2,4-cyclohexadien-1-ylidene)-1,2,4-triazolidin-1-yl]benzoic acid, AldrichCPR
4-[(3Z,5E)-3,5-bis(6-oxocyclohexa-2,4-dien-1-ylidene)-1,2,4-triazolidin-1-yl]benzoic acid
4-[3,5-bis(2-hydroxyphenyl)
4-[3,5-Bis(2-hydroxyphenyl)-[1,2,4]triazol-1-yl]benzoic acid
4-[3,5-Bis(2-hydroxyphenyl)-1,2,4-triazol-1-yl]benzoic acid
4-[3,5-bis(2-hydroxyphenyl)-1H-1,2,4-triazol-1-yl]benzoic acid
4-[3,5-bis(6-oxidanylidenecyclohexa-2,4-dien-1-ylidene)-1,2,4-triazolidin-1-yl]benzoic acid
4-[3,5-bis(6-oxo-1-cyclohexa-2,4-dienylidene)-1,2,4-triazolidin-1-yl]benzoic acid
530D418
A814288
AB0020007
AB0073018
AB01565800_02
AB1008603
AC-8972
ACM1133425758
AK544293
AKOS015855839
AKOS015902587
AKOS025312553
BCP05341
BCP9000594
BDBM50088376
Benzoic acid, 4-(3,5-bis(2-hydroxyphenyl)-1H-1,2,4-triazol-1-yl)-
Benzoic acid, 4-[3,5-bis(2-hydroxyphenyl)-1H-1,2,4-triazol-1-yl]-
BOFQWVMAQOTZIW-UHFFFAOYSA-N
C21H15N3O4
CAS-201530-41-8
CGP-72670
CHEBI:49005
CHEMBL550348
CS-0901
CTK8F0690
D03669
DB01609
Deferasirox (Exjade)
Deferasirox (JAN/USAN/INN)
Deferasirox [USAN:INN:JAN]
Deferasirox [USAN:INN]
Deferasirox, ICL670
Deferasirox(Exjade)
Deferasiroxum
Deferasiroxum [INN-Latin]
DSSTox_CID_28522
DSSTox_GSID_48596
DSSTox_RID_82794
DTXSID1048596
Exjade
Exjade (TN)
F0001-2380
FT-0601564
HMS3655A04
HSDB 7844
HY-17359
ICL 670
ICL 670A
ICL-670
ICL-670A
ICL670
ICL670A
J-013060
Jadenu
Jadenu (TN)
Jadenu Sprinkle
KE-0220
KS-00000G02
LS-186571
LS-187785
MLS003915634
MLS006010080
NCGC00181754-01
NCGC00263572-01
PubChem20503
Q5251502
s1712
SB18926
SCHEMBL1071867
SCHEMBL61756
SCHEMBL62042
SMR002544689
SR-01000931971
SR-01000931971-2
SW219752-1
Tox21_112926
Tox21_112926_1
UNII-V8G4MOF2V9
V0697
V8G4MOF2V9
W-5422
ZINC100022643
ZINC100504305
ZINC100504309
ZINC1481815
ZINC14880008
Paragraph IV (Patent) Challenges for DEFERASIROX
Tradename Dosage Ingredient NDA Submissiondate
JADENU TABLET;ORAL deferasirox 206910 2016-04-21
JADENU TABLET;ORAL deferasirox 206910 2015-10-19
EXJADE TABLET, FOR SUSPENSION;ORAL deferasirox 021882 2011-10-28

US Patents and Regulatory Information for deferasirox

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Msn DEFERASIROX deferasirox TABLET;ORAL 210945-001 Nov 20, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Actavis Elizabeth DEFERASIROX deferasirox TABLET;ORAL 208697-002 Dec 13, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Novartis Pharms Corp JADENU deferasirox TABLET;ORAL 206910-001 Mar 30, 2015 AB RX Yes No   Start Trial   Start Trial Y Y   Start Trial
Novartis Pharms Corp JADENU deferasirox TABLET;ORAL 206910-002 Mar 30, 2015 AB RX Yes No   Start Trial   Start Trial   Start Trial
Novartis JADENU SPRINKLE deferasirox GRANULE;ORAL 207968-002 May 18, 2017 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
Alembic Pharms Ltd DEFERASIROX deferasirox TABLET, FOR SUSPENSION;ORAL 210060-002 Nov 20, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Novartis JADENU SPRINKLE deferasirox GRANULE;ORAL 207968-003 May 18, 2017 RX Yes Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for deferasirox

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis EXJADE deferasirox TABLET, FOR SUSPENSION;ORAL 021882-003 Nov 2, 2005   Start Trial   Start Trial
Novartis JADENU SPRINKLE deferasirox GRANULE;ORAL 207968-001 May 18, 2017   Start Trial   Start Trial
Novartis EXJADE deferasirox TABLET, FOR SUSPENSION;ORAL 021882-001 Nov 2, 2005   Start Trial   Start Trial
Novartis EXJADE deferasirox TABLET, FOR SUSPENSION;ORAL 021882-002 Nov 2, 2005   Start Trial   Start Trial
Novartis Pharms Corp JADENU deferasirox TABLET;ORAL 206910-003 Mar 30, 2015   Start Trial   Start Trial
Novartis JADENU SPRINKLE deferasirox GRANULE;ORAL 207968-003 May 18, 2017   Start Trial   Start Trial
Novartis EXJADE deferasirox TABLET, FOR SUSPENSION;ORAL 021882-001 Nov 2, 2005   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for deferasirox

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0914118 06C0049 France   Start Trial PRODUCT NAME: DEFERASIROX OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE IN FRANCE: EU/1/06/356/001 DU 20060828; REGISTRATION NO/DATE AT EEC: EU/1/06/356/001 DU 20060828
0914118 SPC/GB07/002 United Kingdom   Start Trial SUPPLEMENTARY PROTECTION CERTIFICATE NO SPC/GB07/002 GRANTED TO NOVARTIS AG IN RESPECT OF THE PRODUCT DEFERASIROX AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, ESPECIALLY 4-(3,5-BIS(2-HYDROXYPHENYL)-(1,2,4) TRIAZOL-L-YL) BENZOIC ACID, THE GRANT OF WHICH WAS ADVERTISED IN JOURNAL NO 6179 DATED 24 OCTOBER 2007 HAS HAD ITS MAXIMUM PERIOD OF DURATION CORRECTED, SUBJECT TO THE PAYMENT OF THE PRESCRIBED FEES IT WILL EXPIRE ON 30 AUGUST 2021.
0914118 PA2007001 Lithuania   Start Trial PRODUCT NAME: DEFERASIROXUM; REGISTRATION NO/DATE: EU/1/06/356/001 2006 08 28, EU/1/06/356/002 2006 08 28, EU/1/06/356/003 2006 08 28, EU/1/06/356/004 2006 08 28, EU/1/06/356/005 2006 08 28, EU/1/06/356/00 20060828
0914118 SPC 035/2006 Ireland   Start Trial SPC 035/2006: 20070528, EXPIRES: 20210827
0914118 290 Finland   Start Trial
0914118 PA2007001,C0914118 Lithuania   Start Trial PRODUCT NAME: DEFERASIROXUM; REGISTRATION NO/DATE: EU/1/06/356/001 2006-08-28, EU/1/06/356/002 2006-08-28, EU/1/06/356/003 2006-08-28, EU/1/06/356/004 2006-08-28, EU/1/06/356/005 2006-08-28, EU/1/06/356/00 20060828
0914118 300248 Netherlands   Start Trial 300248, 20170624, EXPIRES: 20210827
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKinsey
McKesson
Baxter
Dow
Mallinckrodt
Merck

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.